Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Trade Name | ABIOCOR |
Classification Name | artificial heart |
Generic Name | artificial heart |
Applicant |
ABIOMED, INC. |
22 cherry hill dr. |
danvers, MA 01923 |
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HDE Number | H040006 |
Supplement Number | S001 |
Date Received | 09/08/2006 |
Decision Date | 11/08/2006 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the post-approval study (pas) design to continue to gather clinical data on the abiocor while it is commercialized. Specifically, the first consecutivetwenty-five (25) pati¢nts implanted with the abiocor will be enrolled into the pas and followed until death (while o~ the device) or other outcome (e. G. Elective termination by family, device malfunction, etc). Additionally, after the first 10 patients, the data maybe presented and reviewed by the circulatory systems devices panel. |
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